Clinical Validation Study for Multimodal Equipment for Teleophthalmology Assessment (META) Device
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 400
- 主要终点
- Image Quality
研究概览
简要总结
We have developed a Multimodal Equipment for Teleophthalmology Assessment (META) device. This novel device is compact, portable and suitable for packaging and express delivery. With this device, there is a potential to implement a new concept of "hospital-at-home" eye care model. The present study is designed to validate the META device for future clinical usage and investigation. We will compare the performance of the META device with those provided by commercial devices in terms of image quality of optical coherence tomography (OCT), anterior segment and fundus camera, and evaluate the level of agreement in lesion detection and quantitative measurements between META and other commercial devices (e.g., Heidelberg Spectralis OCT, Haag-Streit BQ900 Slit-lamp imaging, Canon CR-2 fundus imaging, Zeiss IOL Master 500).
详细描述
The META is an innovative and non-invasive examination instrument for a variety of common eye diseases. The integrated multimodality device combines digital slit lamp, fundus camera, OCT, refractometer, optical biometry and visual acuity test (near and distance) that facilitate a comprehensive ophthalmic examination. In the current study, all participants will undergo the measurements provided by the META and by traditional examination modalities (including digital slit lamp, fundus camera, OCT, refractometer, optical biometry and visual acuity test) in a random order. The participants will need to complete several questionnaires to investigate their preference and confidence to receive the META exams in the future.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years of age and older.
- •Participants with healthy eyes, or patients diagnosed with one or more common eye diseases, including anterior segment eye diseases (conjunctivitis, keratitis, corneal opacity or cataract), fundus diseases (age-related macular degeneration or diabetic retinopathy) and/or refractive error (myopia, high myopia, hyperopia, anisometropia, or presbyopia).
- •Willing and able to participate in all examinations related to this study
- •Visual acuity of 20/400 or better in the study eye(s).
排除标准
- •Ocular trauma or postoperative eyes within 3 months.
- •Study eye(s) with dilated pupil.
结局指标
主要结局
Image Quality
时间窗: in the same 1 day
To evaluate the image quality of the META versus commercial devices. These images include slit-lamp anterior-segment images, colour fundus photographs, and OCT scans. The image quality metrics (e.g., position, focus, contrast, etc.) will be identified by masked qualified ophthalmologists independently and scored according to the same grading scheme
Level of agreement in quantitative measurements provided by META-OCT and by commercial OCT
时间窗: in the same 1 day
OCT images will be captured by META-OCT and by a commercial OCT, and segmented and analyzed with default algorithm to yield quantitative measurements.
次要结局
- Level of agreement in axial length measurement(in the same 1 day)
- Level of agreement in near and far visual acuity measurements(in the same 1 day)
- Exam success rate(in the same 1 day)
- Time spent on the examinations(in the same 1 day)
- Level of agreement in detecting ocular abnormalities.(in the same 1 day)
- Level of agreement in spherical equivalent diopter (SED) and astigmatism vector components (J0 and J45)(in the same 1 day)
- Repeatability in quantitative measurements provided by META-OCT(in the same 1 day)
- Patient experience(in the same 1 day)